We are pleased to announce that the AZENT study “A phase IIa clinical trial to evaluate the safety and efficacy of osimertinib (AZD9291) in first-line patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer and concomitant EGFR T790M mutation at time of diagnosis (AZENT study)” has achieved 100% of recruitment!!
7 Spanish sites are participating in this study and the number of patients included is 22.
Recruitment started in July 2016 and there are currently 50 patients have been recruited (22 patients included and 28 screening failure). Thanks to the study team because there was a high rate of screening failures (28 Screening failures) and it was a big challenge.
From MedSIR, we would like to thank all the study teams for their implication and effort identifying patients that can benefit from their participation. Especially to Dr. Majem at Hospital Sant Pau and Dr. Viteri at Hospital Dexeus, they are the top recruiters in the study.
Thanks to the commitment of all the sites involved in AZENT study, and the constant support from Astrazeneca, we are making effort for open the second stage after the evaluation of the results obtained during the interim analysis, this interim analysis will assess the primary endpoint to evaluate the efficacy of osimertinib (AZD9291), in terms of the objective response rate in patients with advanced non-squamous NSCLC with EGFR mutations and the EGFR T790M mutation at diagnosis. Recruitment of patients will resume until a total of 73 patients opening national and international sites.